The California State Board of Pharmacy (BOP) will vote on new compounding drug regulations this week after being challenged by patients, healthcare experts and firefighters.
The BOP intends to revise its drug compounding regulations, ostensibly to improve patient safety and ensure compliance with U.S. Pharmacopoeia (USP) standards. However, these new regulations would instead block patients’ access to a long list of Category 1 Sterile Compounds, treatments they depend on. One board member says there’s a huge chasm in communications that’s adding angst to the hotly contested issue.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding (APC), exclusively tells 2UrbanGirls, “Last month, the California Board of Pharmacy approved a 15-day comment period for changes to its compounding regulations. Previous public feedback to the Board had been overwhelmingly negative, and we had hoped the Board would listen to stakeholders and make substantive adjustments. Unfortunately, though the Board made some modest tweaks, we still have serious concerns.”
“One big issue is how restrictive the rules are about using certain active ingredients in compounded medications. The proposed regs, like requiring expensive stability studies that cost tens of thousands of dollars, could make it highly unlikely that most pharmacies would offer compounded sterile preparations at all. Many pharmacies can only afford to conduct stability studies for the most common formulations, which means patients who need specialized treatments might be left without options. For example, many firefighters in California have been using inhaled glutathione treatments to support their lungs after exposure to smoke and chemicals. Glutathione is one of the ingredients that would be cost prohibitive for most pharmacies to compound under these rules.
“What’s really frustrating is that the board hasn’t shown how these new rules will actually make patients safer. Instead, they’re creating barriers that could cut off access to personalized medications and treatments many people rely on.”
Although the BOP allowed for a 15 day public comment period, some expressed frustration during public comment that it would have been nice to have the period extended to 45 days.
Board’s treasurer Trevor Chandler expressed sincere concern about the deep distrust between the board and the people who are begging it not to pass the regulations.
“I’d like to see representatives from both sides sit down and try to find common ground,” said Chandler, who was appointed to the board by Governor Gavin Newsom.
The Los Angeles wildfires have impacted some pharmacies in their efforts to provide medication to patients in a timely manner.
“Many compounding pharmacies in California have been working to fill gaps in medication access for patients affected by the wildfires,” explained Brunner. “For instance, Sharon Steen owns Central Pharmacy on Wilshire Boulevard in Santa Monica, California. About half of Ms. Steen’s customer base was based in the fire-ravaged Palisades. She has been offering free shipping to all the evacuees, as many of them are still searching for some sort of housing. It’s just one way compounding pharmacies can ease a bit of the stress of this awful situation for those patients.”
Glutathione has proven crucial in detoxifying harmful toxins, significantly reducing cancer risk among firefighters. Research led by Integrated Healers Action Network (IHAN) has demonstrated its effectiveness. Since the 2017 Tubbs Fire, IHAN has provided glutathione treatments that have healed the lungs of firefighters exposed to dangerous smoke and chemicals. Their Detox for Firefighters pilot programs in 2023 and 2024 showed a 93% reduction in toxins like glyphosate and an 80% decrease in ‘forever chemicals’ (PFAs).
If the Board of Pharmacy votes to ban compounded glutathione, California could become the only state to deny access to this vital treatment and there is no replacement for it.
